calendar
19,709 catalysts · 4,728 grant · 3,152 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
next 91 dayslessmore
MonWedFri
19,709 catalysts · 4,728 grant · 3,152 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBF. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: IWB. Advisory committee: Radiology. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITX. Advisory committee: Radiology. Type: Traditional
Product code: KJJ. Advisory committee: Unknown. Type: Traditional
Product code: PZL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL
Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: PGQ. Advisory committee: EN. Decision: APPR
Supplement type: Panel Track. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MHE. Advisory committee: EN. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIU. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: SBB. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Advisory committee: NE. Decision: OK30
Supplement type: Panel Track. Product code: POH. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: FTR. Advisory committee: SU. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
TRANSDUCER L12-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing
C6-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
L12-5 38mm Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C8-4v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
L9-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
X7-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) — Reason: an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. — Status: Ongoing
S9-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C8-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
mC7-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C5-2 Lumify Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
X6-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
C9-3v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing
L12-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing